ES2843274T3 - Moldable reentry devices and associated systems - Google Patents

Abstract

An intravascular device (300; 800; 1200; 1400; 1500; 1600), comprising: a handle (310; 810; 1210; 1410; 1510; 1610) in a proximal portion (306; 806; 1206; 1406; 1506; 1606); an angled distal portion (302; 802; 1202; 1402; 1502; 1602); and an elongated member (304; 804; 1204; 1404; 1504; 1604) coupled to and extending between the handle (310; 810; 1210; 1410; 1510; 1610) and the angled distal portion (302; 802; 1202 ; 1402; 1502; 1602), wherein the elongated member (304; 804; 1204; 1404; 1504; 1604) includes an outer sheath (324; 824; 1224; 1424; 1524; 1624) comprising a polymer; and a hollow rotating member (322; 822; 1222; 1422; 1522; 1622) within the sheath (324; 824; 1224; 1424; 1524; 1624), wherein the rotating member (322; 822; 1222; 1422; 1522; 1622) engages the distal portion at an angle (302; 802; 1202; 1402; 1502; 1602), and wherein rotation of the rotating member (322; 822; 1222; 1422; 1522; 1622) directly causes the rotation of the distal portion at an angle (302; 802; 1202; 1402; 1502; 1602), wherein the hollow rotating member (322; 822; 1222; 1422; 1522; 1622) comprises a mesh-reinforced polymer layer defining a first length and a second length, wherein the outer sheath (324; 824; 1224; 1424; 1524; 1624) is positioned over the first length of the mesh-reinforced polymer layer; and wherein the angled distal portion (302; 802; 1202; 1402; 1502; 1602) includes a lumen (326; 826; 1226; 1426; 1526; 1626) therethrough, a hollow tube (308) positioned over the second length of the mesh-reinforced polymer layer, the hollow tube (308) comprising a metal and configured to be shaped to form a first section and a second section extending distally at an angle from the first section, and wherein the angle between the first section and the second section remains the same when an interventional device is at least partially within the lumen (326; 826; 1226; 1426; 1526; 1626) of the distal portion (302; 802; 1202 ; 1402; 1502; 1602) and encompasses at least a portion of the first section and at least a portion of the second section.

Description

DESCRIPTION

Moldable reentry devices and associated systems

Technical field

The present invention relates generally to systems and devices for accessing and / or treating vascular abnormalities and / or complications. In particular, various embodiments are directed to intravascular devices that have moldable distal portions to address occlusions within a body vessel, including those related to peripheral vascular disease states, cardiovascular disease, cerebrovascular disease, and others.

Background

Chronic total occlusions ("CTOs") are vascular lesions characterized by heavy atherosclerotic plaque within the blood vessel, resulting in complete (or nearly complete) obstruction of blood flow through the lesion. Such occlusions can occur anywhere in the vascular system of a patient. Since most lesions form gradually over a long period of time, ischemic tissue downstream of the lesion has time to form collateral circulation. For example, in the case of coronary arteries, collateral vessels may form from the proximal artery and connect to the distal artery ("ipsilateral collaterals"), or collateral vessels may form from the other major arterial branches and connect to the distal artery ("contralateral collaterals"). When the injury eventually becomes a total occlusion, collateral circulation is typically sufficient to keep the distal tissue alive, albeit ischemic. Consequently, it is desirable to restore blood flow through or around the blockage in the blood vessels by crossing the CTO and advancing therapeutic devices, such as a balloon angioplasty catheter, to dilate and treat the CTO. Also, in some cases it may be necessary to cross an OTC to access a location along the vasculature distal to the OTC.

OTCs are more difficult to cross than partially occluded lesions because, instead of navigating a pre-existing lumen, a guide must penetrate the lesion or, when penetration of the occlusion is practically difficult and / or complicated, it can be bypassed injury through a subintimal layer of the vascular wall. Figures 1A-1F, for example, are schematic cross-sectional side views of a conventional device used to treat such ^or T ^c . Referring first to Figure 1A, a guidewire 12 and / or a catheter 10 is forced into a subintimal layer SL adjacent to an occlusion O. Once the guidewire 12 and / or catheter 10 pass through the occlusion O, the Device (s) require re-entry into a true TL lumen of vessel V. For example, to re-enter the true TL lumen, many current techniques employ advancing guidewire 12 in such a way that it bends and / or kinks. on itself at its distal end 16 as guide 12 advances distally through subintimal layer SL. As best seen in Figures 1B and 1C, for example, such techniques can create a "subintimal tunnel." As best seen in Figures 1D-1F, once a looped end 14 of guide 12 is distal to a distal end of the OTC, guide 12 can be forced back into the true TL lumen, thereby creating a large H hole and / or flap in vascular wall V. However, forcing reentry using a looped guide can cause complications for the patient, such as unnecessarily extending the subintimal tunnel, perforation of the V vessel, and / or unwanted dissection vessel V requiring additional treatment.

Other current methods to re-enter the true TL lumen during treatment involve the use of one of the currently available reentry devices. However, such reentry devices typically have larger diameters than the original tools used in the procedure. In many procedures, for example, the catheter in use is removed and the introducer sheath replaced with a larger sheath (eg, 7-8 Fr sheath). However, such a transition can cause significant interruptions to the procedure and dramatically increase procedure time and X-ray exposure of the patient. US2009 / 018566 A1 discloses a steerable atherectomy catheter with an angled distal end. Summary

Claim 1 defines the invention and the dependent claims describe the preferred embodiments. Brief description of the drawings

Many aspects of the present disclosure can be better understood with reference to the following drawings. Components in the drawings are not necessarily to scale. Rather, the emphasis is on clearly illustrating the principles of this disclosure. Additionally, components may be shown as transparent in certain views for clarity of illustration only and not to indicate that the illustrated component is necessarily transparent.

Figures 1A-1F are schematic cross-sectional side views of a conventional device used to treat an OTC by traversing the OTC through a subintimal space.

Figure 2A is a side perspective view of an intravascular device in a low profile configuration configured in accordance with one embodiment of the present technology.

Figure 2B is a side perspective view of the intravascular device of Figure 2A with an angled distal portion configured in accordance with one embodiment of the present technology.

Figure 3 is an enlarged side view of the distal portion of the device of Figure 2B without a guide and / or an intravascular catheter placed therethrough.

Figure 4 is an enlarged side view of the distal portion of the device of Figure 2B with an intravascular catheter and guide placed therethrough in accordance with one embodiment of the present technology. Figure 5 is an enlarged cross-sectional view of a portion of the elongated member of the device shown in Figure 7A configured in accordance with one embodiment of the present technology.

Figure 6A is an enlarged cross-sectional view of a portion of the elongated member of the device shown in Figure 3 configured in accordance with one embodiment of the present technology.

Figure 6B is an enlarged cross-sectional view of another portion of the elongated member of the device shown in Figure 3 configured in accordance with one embodiment of the present technology.

Figure 7A is an enlarged side view of the intravascular device of Figure 2B configured in accordance with the present technology.

Figure 7B is an enlarged cross-sectional side view of the intravascular device of Figure 2B mapped in Figure 7A in accordance with the present technology.

Figure 7C is a side view of a forming mandrel configured in accordance with the present technology. Figure 8A is a partially schematic side view of an intravascular device in a low profile configuration, configured in accordance with one embodiment of the present technology.

Figure 8B is a partially schematic side view of the intravascular device of Figure 8A having an angled distal portion configured in accordance with one embodiment of the present technology.

Figure 9 is an enlarged cross-sectional view of a portion of the elongated member of the device shown in Figure 8B in accordance with one embodiment of the present technology.

Figure 10 is a side view of a distal portion of an intravascular device having a reinforcing member configured in accordance with another embodiment of the present technology.

Figure 11 is a partial cross-sectional side view of a distal portion of the intravascular device of Figure 10 disposed within an outer sheath in accordance with the present technology.

Figure 12 is a side perspective view of a distal portion of an intravascular device having two inflatable support rings configured in accordance with present technology.

Figure 13 is a side view of a distal portion of an intravascular device having a single-sided expandable member configured in accordance with present technology.

Figure 14 is a side view of a distal portion of an intravascular device having a reinforcing member and an expandable member configured in accordance with the present technology.

Figures 15A-15G are anatomical cross-sectional side views illustrating a method, not part of the invention, for using an intravascular device and / or one or more interventional devices to cross and / or treat a CTO in accordance with a realization of current technology.

Figures 16A and 16B are side views of a proximal marker configured in accordance with embodiments of the present technology.

Figures 17A and 17B are side views of a proximal marker configured in accordance with another embodiment of the present technology.

Detailed description

This technology generally refers to systems and devices for crossing and dealing with OTCs. The details Specific features of various embodiments of the present technology are described in the present description with reference to Figures 2-17B. Although many of the embodiments are described below with respect to devices and methods for crossing and / or treating CTOs, any vascular occlusion in addition to those described in the present disclosure can be crossed and / or treated within the scope of the present technology (e.g. eg, complete occlusions, partial occlusions, occlusions resulting from a thrombus, occlusions resulting from an embolism, occlusions resulting from atherosclerosis, etc.). In addition, other embodiments of the present technology may have configurations, components, or procedures other than those described in the present disclosure. For example, other embodiments may include additional elements and features beyond those described in the present description, or other embodiments may not include various of the elements and features shown and described in the present description.

For ease of reference, identical reference numerals are used throughout this description to identify similar or analogous components or features, but use of the same reference numeral does not imply that the parts should be construed as identical. In fact, in many examples described herein, identically numbered parts are different in structure and / or function.

Generally, unless the context indicates otherwise, the terms "distal" and "proximal" within this description refer to a position relative to an operator or an operator's control device. For example, "proximal" can refer to a position closer to an operator or an operator's control device, and "distal" can refer to a position that is further away from an operator or an operator's control device.

I. Selected modalities

1 inch = 25.4 mm

Figure 2A is a side perspective view of an intravascular device 300 in a low profile or generally straight configuration in accordance with one embodiment of the present technology. The intravascular device 300 may include a proximal portion 306 having a handle 310, as well as a distal portion 302 and an elongated shaft 304 that extends between the handle 310 and the distal portion 302. The handle 310 can be configured to position in one location external to a patient, and elongated shaft 304 may be configured to locate distal portion 302 intravascularly at or near complete or partial occlusion within a patient's blood vessel. Intravascular device 300 may have a lumen 326 (Figure 5) that extends proximally from an opening 330 at a distal end of device 300 to an outlet 331 in handle 310 of device 300.

Figure 2B is a side view of the intravascular device 300 with the distal portion 302 in an angled or treatment configuration (labeled in Figure 2B as 302 '). In some embodiments, the distal portion 302 can be "cold worked" during manufacture into a permanent angled shape. In other embodiments, the distal portion 302 of the intravascular device 300 in Figure 2A may be comprised of a malleable or moldable material so that a clinician can manually transform the generally straight distal portion 302 into an angled distal portion 302 '. For example, intravascular device 300 may come as part of a kit that includes one or more shaping mandrels (see, for example, mandrel 370 shown in Figure 7C). The mandrels can have a variety of configurations (eg, different diameters, shapes, angles, etc.) to address the different needs presented by the vasculature of the particular patient. The clinician can position the mandrel at least partially in or on the distal portion 302 and bend or manipulate the distal portion 302 at the angle or shape of the mandrel. In some embodiments, the physician can manually bend the distal portion 302 to a desired angle based on the specific requirements presented by a particular procedure (eg, crossing, directing, targeting a particular area within the vasculature, etc.). For example, the physician may manipulate the distal portion 302 without a mandrel, or in some embodiments, the mandrel may be flexible so that the mandrel bends with the distal portion 302 and functions primarily to prevent the internal diameter of the distal portion. 302 collapses or kinks during the shaping process.

Often times, the physician may find it beneficial and / or necessary to use multiple shapes and / or angles during a procedure. As such, the distal portion 302 of the present technology is configured to be repeatedly angled, molded, and / or manipulated during a procedure. For example, a clinician may initially use a first angle (for example, 45 ° angle) or shape, but realizes, after inserting device 300, that a larger angle (for example, 70 °, may be required). 60 °, 50 °, etc.), a smaller angle (for example, 30 °, 20 °, 15 °, 10 °, etc.), or a different way to navigate the vasculature and / or re-enter the true lumen. The physician may remove device 300 from the patient and bend, tilt, shape, and / or otherwise manipulate the device to a second angle or shape that is different from the first angle or shape. The physician can then reinsert device 300 at the second angle or shape. The physician can remove and reshape or manipulate the distal portion 302 as many times as desired during a single procedure (eg, 2 times, 3 times, 4 times, etc.). In some embodiments, the distal portion 302 can be bent into multiple portions along its longitudinal axis.

Although the shape of the distal portion 302 may be affected by the practitioner and / or the mandrel, once it is establishes a desired shape, the distal portion 302 has sufficient rigidity to retain its desired shape when subjected to tortuous anatomy or when a guide and / or the interventional device is placed therethrough. The moldable distal portion 302 can be made of shape memory plastic, Nitinol, stainless steel, titanium, tungsten, tantalum, Elgiloy, and other suitable materials. In some embodiments, the moldable distal portion may be between about 0.25 inches and about 1.50 inches in length along its longitudinal axis. In some embodiments, the moldable distal portion may be a different color than the rest of the elongated shaft for identification purposes. In other embodiments, however, the moldable distal portion may have a different arrangement and / or include different features.

Figure 5 is an enlarged cross-sectional view of a portion of the elongated shaft 304 proximal to the distal portion 302. Figures 7A and 7B show an enlarged side view and a partial cross-sectional side view, respectively, of the intravascular device of the Figure 2B. Referring to Figures 5, 7A, and 7B together, elongated shaft 304 may include one or more layers configured to rotate along a central axis independently of one another. For example, elongated shaft 304 may include an outer sheath 324 and a tubular rotatable member 322 within outer sheath 324. As shown in Figure 7B, a proximal section of outer sheath 324 may be attached to a first knob. control 342 (eg, in a first portion 343), and a proximal section of the rotary member 322 can be attached to a second control knob 362 (eg, in a second portion 363). Consequently, rotational motion applied to first button 342 (eg, by a physician) causes rotation of outer sheath 324, and rotation of second button 362 causes rotation of rotary member 322. In some embodiments, a region Proximal 360 of outer sheath 324 is reinforced to provide stress relief to outer sheath 324 and / or rotating member 322 during rotation. Outer sheath 324 can be made of a flexible polymer (eg, polyurethane, polyether block amide copolymer sold under the trademark PEBAX, etc.) or any suitable material, and can have an outer diameter of about 1.9 Fr at about 5 Fr. In other embodiments, however, the outer sheath 324 may have a different arrangement and / or include different features. The intravascular catheter can accommodate a variety of guide sizes (eg, 0.010 inches, 0.014 inches, 0.018 inches, 0.035 inches, and 0.038 inches).

Rotating member 322 can be made of metal, plastic, and / or any suitable material with sufficient rigidity to adequately transfer rotational forces and / or provide an accurate response at its distal end when actuated by a clinician located in a proximal portion 306 of the device. . 300. Rotating member 322 can be a solid, slotted, coiled, and / or braided tube (eg, a mesh-reinforced polyimide) and, in some embodiments, rotating member 322 can have any suitable shape and / or configuration. In some embodiments, intravascular device 300 may include a lubricating coating between rotating member 322 and outer sheath 324 to allow frictionless or relatively low friction manipulation of rotating member 322 within sheath 324 at various anatomical tortuosities. Without being bound by theory, it is believed that such stratification renders the impact of tortuosity on torsional response negligible relative to torque transmission.

The inner lumen 326 of the rotating member 322 may be coated with a lubricating coating 320 (eg, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), hydrophilic, etc.) applied directly to the inner walls of the rotating member 322. The inner lumen 326 extends distally from an opening 331 in the handle 310 to an opening 330 in a distal portion 302. The inner liner 320 allows fluid, guides, and / or other intravascular devices (collectively referred to herein as "interventional devices D ") are slidably positioned within lumen 326 of rotating member 322. For example, handle 310 may include an opening 331 for insertion of an interventional device such as the crossover device described in International Patent Application No. . PCT / US2010 / 047170, filed August 30, 2010, entitled "SYSTEMS, METHODS AND DEVICES FOR ABLATION, CROSSING, AND CUTTING OF OCCLUSIONS." In some embodiments, however, the handle 310 may have a different arrangement and / or include different features.

Figure 3 is a side view of the distal portion 302 of the intravascular device 300 of Figure 2B without an interventional device D placed therethrough, and Figure 4 is a side view of the distal portion 302 that includes an interventional device. intervention D. Referring to Figures 3 and 4 together, the distal portion 302 may be a generally hollow tube having a junction region 316 carried, attached, and / or contiguous to a distal region 305 of the elongated shaft 304. The distal portion 302 may also include an angled region 318 that extends distally at an angle at ⁰ from junction region 316 and terminates in an atraumatic distal tip 334.

In some embodiments, attachment region 316 of distal portion 302 is attached to rotating member 322 such that rotation of rotating member 322 causes rotation of distal portion 302. For example, as shown in Figure 6A, the Distal portion 302 may be defined by an angled tube 308, and at least a portion of the attachment region 316 of the angled tube may be positioned over at least a portion of a distal region of the rotatable member 322. The overlapping portions may be bond next (eg by adhesive, crimp, solder, etc.). Outer sheath 324 can advance over rotating member 322 until a distal end of outer sheath 324 contacts a proximal end of angled tube 308. Consequently, the transition between outer sheath 324 and distal portion 320 can be perfect, allowing a low profile and maximum crossover capability.

In embodiments where the distal portion cannot be molded by the physician, the distal portion 302 can be made of stainless steel, Nitinol, Elgiloy, other metals, and / or similar rigid materials that allow the distal portion 302 to retain its curvature and / or shape. at an angle while passing through the tortuous vasculature and / or when an interventional device (such as interventional device D) is slidably positioned through lumen 326 at or distal to a curve 350 in distal portion 302. Many current devices have distal portions that are heat treated to have an angled configuration. However, such heat-treated devices do not retain their shapes once an interventional device D passes through them and / or the device is subjected to tortuous anatomy. In contrast to such current devices, the non-moldable distal portion 302 of the present technology is not heat treated, and rather comprises a rigid hollow tube 308 that is "cold worked" into a permanent angled shape that is unaffected by anatomical tortuosity and / or placement of an interventional device D across it.

Regardless of whether the distal portion is moldable or non-moldable, the angle a ⁰ remains the same even as an interventional device D advances through lumen 326 of distal portion 302 and extends through aperture 330 in distal tip 334. Consequently, the angled distal portion 302 allows predictable angulation of a separate intravascular device and / or guide, regardless of the shape of the separate intravascular device or guide. Also, it is important to note that angled distal portion 302 is not attached to any control wire and / or actuator that can be manipulated in proximal portion 306 of device 300 to cause deflection in distal portion 302. In some embodiments , all or a portion of distal portion 302 may be coated or comprised at least in part of radiopaque material to aid in positioning the device.

Even with the angled distal portion 302, the overall profile of the intravascular device 300 is not greater than 7 Fr. In some embodiments, the overall profile of the intravascular device is not greater than 5 Fr. The ^0- angle of the distal portion 302 can vary (for example, between about 1 and about 90 degrees). In some embodiments, for example, the angle at ⁰ is between about 10 and about 40 degrees. In other embodiments, the angle at ⁰ is between about 25 degrees and about 35 degrees (eg, about 25 degrees, about 30 degrees, about 35 degrees, etc.). In some embodiments, the distal portion 302 can be configured to have any suitable angle and / or length relative to the length of the intravascular device 300.

The distal tip 334 can be atraumatic and have a generally tapered shape. In some embodiments, distal tip 334 may also be configured to engage another member of intravascular device 300. For example, aperture 330 at the distal end of distal tip 334 may define a passageway to receive a guide (not shown) to delivery of the treatment device using catheter over guide ("OTW") or rapid exchange ("RX") techniques. In other embodiments, however, the distal tip 334 may have a different arrangement and / or include different features. The distal tip 334 can also be radiopaque to aid device positioning.

Figure 8A is a side view of an intravascular device 800 in a low profile or generally straight configuration configured in accordance with one embodiment of the present technology. Intravascular device 800 may include a handle or luer 810 in a proximal portion 306, a distal portion 802, and an elongated shaft 804 that extends between luer 810 and distal portion 802. Luer 810 may be configured to position at an external location. to the patient, and elongated shaft 804 may be configured to locate distal portion 802 intravascularly at or near complete or partial occlusion within a blood vessel of the patient. Intravascular device 800 may have a lumen 826 that extends from an opening 330 in a distal end of device 300 to an outlet 331 in handle 310 of device 300.

Figure 8B is a side view of the intravascular device 800 with the distal portion 802 in an angled or treatment 802 'configuration. In some embodiments, the distal portion 802 is "cold worked" during manufacture in a permanent, angled shape. In other embodiments, the distal portion 802 of the intravascular device 800 in Figure 8A can be made of a malleable or moldable material so that a clinician can manually transform the generally straight distal portion 802 into an angled distal portion 802 '. For example, the intravascular device 800 may come as part of a kit that includes a shaping mandrel 370 (see Figure 7C). The clinician may position mandrel 370 at least partially in or on distal portion 802 to prevent the internal diameter of distal portion 802 from collapsing or kinking while manually bending to the desired shape. In some embodiments, the physician can manually bend the distal portion 802 to a desired angle based on the specific requirements presented by a particular procedure (eg, crossing, directing, targeting a particular area within the vasculature, etc.). Although the shape of the distal portion 802 can be manipulated by the clinician, once the desired shape is established, the distal portion 802 'has sufficient rigidity to retain its desired shape when subjected to tortuous or guided anatomy and / or or an intervention device placed through it. The moldable distal portion 802 can be made from moldable member plastic, Nitinol, stainless steel, titanium, tungsten, Elgiloy, and others. The distal moldable portion may be between about 0.25 inches and about 0.30 inches in length throughout along its longitudinal axis.

Figure 9 shows an enlarged cross-sectional view of the intravascular device of Figure 8B. Elongated shaft 804 may include an outer layer 824 and a mesh-reinforced polyimide layer 822 within the outer layer 824. During manufacture, a polymer (eg, polyether block amide copolymer sold under the trademark PEBAX ) can be fused onto mesh 822 to form outer layer 824. In some embodiments, a proximal region 860 of outer layer 824 can be reinforced with additional material (for example, an additional polyether block amide copolymer sold under the trademark PEBAX melts onto mesh) to provide stress relief to outer shell 824 when rotated. Rotational motion applied to luer 810 (eg, by a physician) causes rotation of outer shell 824 along the entire longitudinal axis of elongated axis 804. The outer shell may be made of a flexible polymer (eg, polyether block amide copolymer sold under the trademark PEBAX). The inner walls 826 of the mesh may also include a lubricating coating 820 as described above.

The mesh layer 822 may extend partially or completely along the longitudinal axis of the distal portion. The 822 mesh layer is expected to provide high burst strength (eg, greater than or equal to 2000 psi) and additional resistance to kinking.

Figure 10 is a perspective view of a distal portion of an intravascular device 1200 having a reinforcing member 1250 configured in accordance with another embodiment of the present technology. In the illustrated embodiment, the reinforcing member 1250 may have a "hump shape" configured to allow for additional deflection of the vascular wall. The reinforcing member 1250 can be made of metal and / or plastic materials. The reinforcing member 1250 may be supplied in a low profile or delivery configuration, then expanded upon proximal retraction of an outer sheath 1300 (see Figure 11) to add additional support or stability to the distal portion 1202 of the intravascular device 1200. In In some embodiments, reinforcing member 1250 could automatically and / or manually extend and / or retract from a layer and / or lumen of elongated shaft 1204 (eg, outer sheath 1224) to add stability. In some embodiments, sheath 1300 may be partially retracted to selectively control the angle of distal portion 1202 between about 0 and about 90 degrees.

Figure 12 illustrates an intravascular device 1400 configured in accordance with another embodiment of the present technology. As shown in Figure 12, intravascular device 1400 may have one or more inflatable or expandable rings 1402 configured to position and support a distal portion 1404 of device 1400 within the vessel. For example, once distal portion 1404 is positioned at a target site, rings 1402 can expand to force at least a portion of distal portion 1404 away from an adjacent occlusion or vascular wall. In embodiments where the intravascular device includes a moldable distal portion, the expansion of the rings 1402 helps guide the deflection of the distal portion. However, in embodiments where the intravascular device 1400 includes a preformed distal portion, the expansion of the rings 1402 does not generally affect the angulation of the distal portion. Rather, in such embodiments, rings 1402 can reinforce the preformed angle of device 1400 and also stabilize the device with respect to surrounding anatomy. In some embodiments, rings 1402 can independently expand or unfold to provide additional directionality and / or stability to device 1400.

Figure 13 is a side view of another embodiment of an intravascular device 1500 having a single-sided expandable member 1502. Once expanded, expandable member 1502 provides additional angulation to distal portion 1504 and support for device 1500. For For example, in some embodiments, expandable member 1502 helps deflect distal portion 1504 out of the vessel wall and / or redirect device 1500.

Figure 14 shows yet another embodiment of an intravascular device 1600 having a combination of expandable members 1602 (eg, balloons, inflatable rings, etc.) and a clamp 1604. Such a combination is expected to provide both directionality and stability to the portion. distal 1606. Expandable members 1602 can inflate or expand regardless of deployment of clamp 1604. In some embodiments, an expandable member 1602 can be inflated or deflated, thereby allowing preformed wire 1604 to bend and provide additional angle to the device. 1600. In some embodiments, rings 1602 and / or preformed wire 1604 may also be covered for delivery through the vasculature until the distal portion of the device is positioned at a desired location within the vessel, as previously described with reference to Figures 12 and 13.

II. Selected delivery systems and illustrative methods

The ability to percutaneously access the remote vasculature is well known and is described in the patent and medical literature. Once percutaneous access is achieved (for example, via the femoral or iliac veins), interventional tools and support catheters can be advanced to the target vessel or the CTO and positioned at or near the CTO in a variety of shapes, as described in the present description.

Figures 17A-17G illustrate an example of use of an intravascular device 300 and / or one or more interventional devices to cross over and / or treat a CTO. Referring first to Figure 17A, a guide 800 may be advanced along the vasculature until a proximal region of the OTC prevents the guide 800 from moving more distally and inadvertently or intentionally enters the subintimal layer SL. (Figure 17b). At this point, as best seen in Figure 17C, distal portion 302 of device 300 can advance distally over guide 800 and into subintimal layer SL. As shown in the top view of Figure 17D, once in the subintimal layer, the angled distal portion 302 can advance distally through the subintimal layer SL until the distal portion 302 of device 300 is positioned in or distal to a distal end of the OTC. While the distal angled portion 302 moves through the subintimal space, the angled region 318 is generally perpendicular to a true lumen TL of the V vessel. The distal portion 302 can be advanced through the subintimal layer SL using imaging systems. known techniques and techniques such as fluoroscopy, X-rays, magnetic resonance imaging, ultrasound or others. Radiopaque material may be incorporated into guide 800, distal portion 302, and / or along any portion of intravascular device 300 to provide additional visibility under the imaging guide. Such marker materials can be made of tungsten, tantalum, platinum, palladium, gold, iridium, or other suitable materials.

Once the distal portion 302 reaches the distal end of the OTC, the clinician can operate the knob 362 (Figures 2A-2B and 7A-7B) or rotate the handle (Figures 8A and 8B) to rotate the distal portion 302 (through through rotary knob member 322) so that angled region 318 is directed toward the true lumen TL of vessel V, as shown in the top and side views of Figures 17E-17F, respectively.

As shown in Figures 16A and 16B and Figures 17A and 17B, in particular embodiments, the intravascular device may include a mark 352 on the luer or handle that aligns with curve 350 so that a physician can identify (from a extracorporeal location) the direction of the angle at ⁰ and / or projection of the region 318 at an angle. For example, knob 362 may have a mark 352 at a circumferential position corresponding to fold 350.

A piercing element (not shown) can be advanced through distal portion 302 to penetrate the subintimal lining and facilitate reentry into the true TL lumen. As described above, a guide 800 and / or an interventional device ID can advance through aperture 330 and into the true lumen TL of vessel V in a direction and / or angle dictated by the ^0- angle of the portion. distal 302 (as best seen in Figure 15G).

In some embodiments, intravascular device 300 may include one or more distal markers that could be used by the various imaging techniques described above. For example, in some embodiments, distal portion 302 could have markings (eg, holes, grooves, radiopaque markings, etc.) along its length so that when an interventional device reaches distal portion 302, the markings Corresponding data on the interventional device will align and confirm that the guide and / or the interventional device have reached the distal portion 302 of the device 300. In addition, such distal markings could be used when the device is used as a diagnostic catheter or angiographic catheter. Saline or dye can wash through the device and exit distally through the various ports.

It should be noted that the intravascular device described in the present description is not limited to a reentry device. For example, various embodiments of the present technology could also be used when attempting to reach areas of the vasculature with tortuosity and / or provide direction while traversing said anatomy. Because the angled shape of the distal portion remains faithful and does not lose its configuration, multiple wires and other devices could be fed through the elongated shaft from an opening 331 in the proximal portion 306 and selectively positioned without the concern of having You compensate for any changes to the preset dimensions before entering the anatomy. In some embodiments, for example, the system can be used to reach a complex location that has multiple bends, twists, and anatomical variability.

IV. Conclution

The above detailed descriptions of embodiments of the technology are not intended to be exhaustive or limit the technology to the precise manner described above. Although specific embodiments and examples of the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as will be recognized by those skilled in the relevant art. For example, although the steps are presented in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described in the present description can also be combined to provide additional embodiments.

From the foregoing, it will be appreciated that specific embodiments of the technology have been described in the present description for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. . Where context permits, singular or plural terms may also include the plural or singular term, respectively.

Furthermore, unless the word "or" is expressly limited to a single item exclusive to the other items in reference to a list of two or more items, the use of "or" in such a list should be construed as including (a) any element of the list, (b) all the elements of the list, or (c) any combination of the elements of the list. Furthermore, the term "comprising" is used throughout to mean that it includes at least the listed feature (s) so that a greater number of the same feature and / or additional types of features are not excluded. Other features. It will also be appreciated that specific embodiments have been described herein for illustrative purposes, but that various modifications can be made without deviating from technology. Furthermore, although the advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments necessarily need to exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology may encompass other embodiments not expressly shown or described in the present disclosure. The scope of the invention is defined solely by the claims.

Claims (14)

1. An intravascular device (300; 800; 1200; 1400; 1500; 1600), comprising: a handle (310; 810; 1210; 1410; 1510; 1610) in a proximal portion (306; 806; 1206; 1406; 1506; 1606); an angled distal portion (302; 802; 1202; 1402; 1502; 1602); Y an elongated member (304; 804; 1204; 1404; 1504; 1604) coupled to and extending between the handle (310; 810; 1210; 1410; 1510; 1610) and the distal angled portion (302; 802; 1202; 1402; 1502; 1602), wherein the elongated member (304; 804; 1204; 1404; 1504; 1604) includes an outer sheath (324; 824; 1224; 1424; 1524; 1624) comprising a polymer; and a hollow rotating member (322; 822; 1222; 1422; 1522; 1622) within the sheath (324; 824; 1224; 1424; 1524; 1624), wherein the rotating member (322; 822; 1222; 1422; 1522; 1622) engages the distal portion at an angle (302; 802; 1202; 1402; 1502; 1602), and wherein rotation of the rotating member (322; 822; 1222; 1422; 1522; 1622) directly causes the rotation of the distal portion at an angle (302; 802; 1202; 1402; 1502; 1602), wherein the hollow rotating member (322; 822; 1222; 1422; 1522; 1622) comprises a mesh-reinforced polymer layer defining a first length and a second length, wherein the outer sheath (324; 824; 1224; 1424; 1524; 1624) is positioned over the first length of the mesh-reinforced polymer layer; Y wherein the angled distal portion (302; 802; 1202; 1402; 1502; 1602) includes a lumen (326; 826; 1226; 1426; 1526; 1626) through it, a hollow tube (308) positioned over the second length of the mesh-reinforced polymer layer, the hollow tube (308) comprising a metal and configured to be shaped to form a first section and a second section extending distally in an angle from the first section, and wherein the angle between the first section and the second section remains the same when an interventional device is at least partially within the lumen (326; 826; 1226; 1426; 1526; 1626) of the distal portion (302; 802; 1202; 1402; 1502; 1602) and encompasses at least a portion of the first section and at least a portion of the second section. The device (300; 800; 1200; 1400; 1500; 1600) of claim 1, wherein the angle between the first section and the second section remains the same when a guide is at least partially within the lumen (326; 826 ; 1226; 1426; 1526; 1626) of the distal portion (302; 802; 1202; 1402; 1502; 1602). The device (300; 800; 1200; 1400; 1500; 1600) of claim 1 or claim 2, wherein the distal portion (302; 802; 1202; 1402; 1502; 1602) is not heat set. The device (300; 800; 1200; 1400; 1500; 1600) of claim 1, wherein the angle is approximately 30 degrees. The device (300; 800; 1200; 1400; 1500; 1600) of any of claims 1 to 4, wherein the distal portion (302; 802; 1202; 1402; 1502; 1602) further comprises an atraumatic distal tip (334). 6. The device (300; 800; 1200; 1400; 1500; 1600) of any of claims 1-5 wherein: the rotating member (322; 822; 1222; 1422; 1522; 1622) has a distal end and a proximal end; the distal end of the rotating member (322; 822; 1222; 1422; 1522; 1622) engages the distal portion (302; 802; 1202; 1402; 1502; 1602); and the proximal end of the rotating member (322; 822; 1222; 1422; 1522; 1622) engages a knob located on the handle (310; 810; 1210; 1410; 1510; 1610). The device (300; 800; 1200; 1400; 1500; 1600) of any one of claims 1 to 6, wherein at least a portion of the distal portion (302; 802; 1202; 1402; 1502; 1602) is radiopaque. The device (300; 800; 1200; 1400; 1500; 1600) of any one of claims 1 to 7 wherein, while the distal portion (302; 802; 1202; 1402; 1502; 1602) is located external to the patient, the distal portion (302; 802; 1202; 1402; 1502; 1602) can be moved between a first configuration configured to be delivered intravascularly within the vasculature of a patient; and a second configuration configured to be delivered intravascularly into the vasculature of the patient, wherein the second configuration is different from the first configuration. The device (300; 800; 1200; 1400; 1500; 1600) of claim 8, wherein: the first configuration forms a first angle with respect to a longitudinal axis of the elongated member (304; 804; 1204; 1404; 1504; 1604); and the second configuration forms a second angle with respect to the longitudinal axis of the elongated member (304; 804; 1204; 1404; 1504; 1604), wherein the second angle is different from the first angle. The device (300; 800; 1200; 1400; 1500; 1600) of claim 8, wherein: the first configuration is a rounded configuration having a first diameter; Y the second configuration is a rounded configuration that has a second diameter that is different from the first diameter. The device (300; 800; 1200; 1400; 1500; 1600) of claim 8, wherein: the first configuration is a rounded configuration; and the second configuration is a folded configuration. The device (300; 800; 1200; 1400; 1500; 1600) of claim 8, wherein the distal portion is further movable to a third configuration that is different from at least one of the first configuration and the second configuration . The device (300; 800; 1200; 1400; 1500; 1600) of claim 8, wherein the distal portion (302; 802; 1202; 1402; 1502; 1602) can be further moved to a third configuration that is different from the first configuration and the second configuration, and wherein, when in the third configuration, the distal portion (302; 802; 1202; 1402; 1502; 1602) is configured to be administered intravascularly. The device (300; 800; 1200; 1400; 1500; 1600) of claim 8, wherein: the rotating member (322; 822; 1222; 1422; 1522; 1622) has a distal end and a proximal end; the distal end of the rotating member (322; 822; 1222; 1422; 1522; 1622) engages the distal portion (302; 802; 1202; 1402; 1502; 1602); and the proximal end of the rotary member (322; 822; 1222; 1422; 1522; 1622) engages a knob located on the handle (310; 810; 1210; 1410; 1510; 1610).